Formative evaluation: What the FDA and IEC 62366 require
The regulations relevant to usability engineering require formative evaluations.
Usability validation: Compliant with IEC 62366-1 and FDA
Usability validation is a review using objective means to determine whether specified users can effectively and efficiently achieve the specified usage goals (intended purpose) in the specified context of use.
User Interface of Unknown Provenance UOUP
1. Definition of the term UOUP (according to IEC 62366) The IEC 62366-1:2015 (the standard for “Application of usability engineering to medical devices”) introduces the term UOUP and defines it as follows: A UOUP (User interface of unknown provenance) is a user interface or parts of a user interface with an unknown development process for…
DetailsCognitive walkthrough and usability verification
The cognitive walkthrough is one of many methods for testing the usability of products. There are many others. An overview of these methods, particularly those for validation of usability, can be found here.
DetailsUser Request and User Requirement
How do you identify the real user requirements (customer requirements)? Simple: you ask the users what their requirements are. Wrong! That won’t tell you what the user requirements are, just the user requests! This confusion can spell disaster for your project!